Z-0358-2024Class II

GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 00024315007, 00024330007...

Name: Z-0358-2024 GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 00024315007, 00024330007...
Creator: Instrumentation Laboratory
Published: 2023-09-29
License: https://open.fda.gov/license/

Instrumentation Laboratory Co. / initiated 2023-09-29 / Open, Classified / root cause: labeling and UDI

FDA source

Instrumentation Laboratory began a recall of GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 00024315007, 00024330007, 00024345007, 00024360007 on 2023-09-29. FDA classified it as Class II and gives the reason as "Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (i.e., positive bias) of pO2 results in the low range (at pO2 levels less than 60 mmHg) that are outside of labeled...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0358-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-09-29
Posted: 2023-11-21
Recalling firm: Instrumentation Laboratory Co.
Product: GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 00024315007, 00024330007, 00024345007, 00024360007
Product code: CHL Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Reason for recall: Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (i.e., positive bias) of pO2 results in the low range (at pO2 levels less than 60 mmHg) that are outside of labeled performance specifications for pO2. The positive bias may lead to false positive for medical decision levels at pO2 < 60 mmHg, which may result in failure to detect and/or adequately treat hypoxemia and lead to a delay in treatment. The quality control procedures for the Non-iQM GEM Premier 3000 may not detect the non-conformance.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: An URGENT MEDICAL DEVICE RECALL notification letter dated 9/29/23 was sent to customers. Mandatory Customer Actions Please take the following immediate actions: " Check your inventory for the GEM Premier 3000 Non-iQM PAK (cartridge) lot numbers listed in Appendix A. " Discontinue use and destroy any GEM Premier 3000 Non-iQM PAK (cartridge) lot numbers listed in Appendix A. " Document the destruction on the Mandatory Tracking Response Record and return the completed and signed form to Werfen Regulatory at the fax number or e-mail address listed below. " Contact Werfen Customer Service at 1-800-955-9525 to order replacement PAKs (cartridges). " Share this information with your laboratory staff and follow your internal procedures. " Forward this notification to all affected locations within your facility. " Retain a copy of this notification for your records. Mandatory Response Tracking Record " Return the completed and signed Mandatory Response Tracking Form to: " Fax No.: 1-781-861-4207 Or " E-mail: [email protected] Contact Information for Questions " For technical questions, contact the Technical Support Center at 1-800-678-0710. " For replacement cartridges, contact Customer Service at 1-800-955-9525.
Quantity in commerce: 2448 units
Distribution: US States: MA, MN, NY. India.
Product codes and lots: Part No. 00024307507: UDI-DI: 08426950087946, Lot Numbers: 323031H, 323531D, 324231M, 325031D, 324931F, 323831E, 323031I, 324231I, 324831E, 325631C; Part No. 00024315007: UDI-DI: 08426950082484, Lot Numbers: 323441B, 323641G, 323041H, 323541D, 324141J, 324841E, 325041D, 325641C; Part No. 00024330007: UDI-DI: 08426950082514, Lot Numbers: 323051H, 323551D, 323651G, 324151J; Part No. 00024345007: UDI-DI: 08426950082545, Lot Numbers: 323761H; Part No. 00024360007: UDI-DI: 08426950082569, Lot Numbers: 323771H, 323471B, 324871E;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0358-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0357-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-29	2023-11-20
Z-0358-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-29	2023-11-20
Z-0359-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-29	2023-11-20

Product code CHL

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)